MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON IDRIVE ULTRA POWERED HANDLE 1; STAPLE, IMPLANTABLE

Model Number IDRVULTRA1

Device Problem Unintended Arm Motion (1033)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a lobectomy, the device started unexpected calibration in the nurse's hands after the first fire, and the jaws also moved by themselves.The reload was replaced with a new one and there was no problem.The last known patient status is good.Operating time was extended less than 30 minutes.There was no additional tissue resection.Nothing fell into the patient cavity.There was no bleeding over 500 cc's.

Manufacturer Narrative

(b)(4).Product has not yet been returned and this complaint will be closed as no sample.If product returns, the complaint will be reopened.

• Brand Name: IDRIVE ULTRA POWERED HANDLE 1
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven ; 2034925267
• MDR Report Key: 5191086
• MDR Text Key: 30219991
• Report Number: 1219930-2015-00968
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IDRVULTRA1
• Device Catalogue Number: IDRVULTRA1
• Device Lot Number: N4M0010LX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2015
• Initial Date FDA Received: 10/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1